Knotless implants, instruments, and methods

ABSTRACT

A suture anchor and methods of use thereof are disclosed. The suture anchor comprises an anchor body having a slot formed in the body and a passage extending through the body in a first direction. The passage is sized to permit a suture to traverse the body through the passage. The suture anchor also has a shaft with a sharp portion, and the slot and the passage intersect within the anchor body. The shaft is movable relative to the anchor body within the slot from a first position in which the sharp portion and the passage do not intersect, to a second position in which the sharp portion and the passage intersect. The shaft can penetrate a suture or multiple suture strands to fix the suture or suture strands relative to the suture anchor.

CLAIM OF PRIORITY

This application is a division of U.S. application Ser. No. 15/897,254,filed Feb. 15, 2018, which claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/462,182, filed on Feb. 22, 2017, the benefit ofpriority of each of which is claimed hereby, and each of which isincorporated by reference herein in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to surgical implant systems, includingimplants, instruments, and methods for installing an implant.Specifically, the present disclosure relates to knotless implants, alsoreferred to as suture anchors, for securing soft tissue to bone.

BACKGROUND

Various implant systems have been created for repairing soft-tissuedamage in different surgical contexts. As an example, suture anchorshave been utilized to repair tears to a patient's labrum in the shoulderor hip, or a tear to a patient's meniscus in the knee. In some cases,the suture anchor is driven into a pre-drilled bone hole, and suture ispassed through the particular soft tissue in order to tension the sutureconstruct and draw the tissue back into its normal anatomical positionagainst the bone. At the end of the repair, a knot can be used to assistin drawing the torn soft tissue back to its anatomically-correctposition and/or to secure the tissue in position. However, the use ofknots to repair soft-tissue tears can result in a number of issues forthe patient. For example, knot migration can occur after the initialrepair whereby the position of the knot moves during normal physicalmotion by the patient. In the case of a labrum repair in the shoulder,for example, if the knot migrates far enough, it can become interposedbetween the glenoid and the humerus and potentially cause chondralabrasion and discomfort or more serious issues for the patient. Further,knot loosening can also occur resulting in an ineffective repair causingthe soft tissue to move out of position and not heal correctly.

Knotless suture anchors have also been developed, but such anchorssuffer from deficiencies in securing the suture relative to the anchor.Often, a friction-lock is used in which the suture is pressed againstthe anchor in an attempt to secure the suture relative to the anchor. Ofcourse, such constructs can suffer from slippage and loss of tensionbetween the suture and the anchor at the point of the friction-lock.

The presently disclosed subject matter seeks to address numerous issueswith knotted and knotless suture anchors by proving improved knotlessimplants, instruments, and methods.

SUMMARY

To better illustrate the system disclosed herein, a non-limiting list ofexamples is provided here:

Example 1 is a suture anchor comprising: an anchor body having a slotformed in the body and a passage extending through the body in a firstdirection, the passage being sized to permit a suture to traverse thebody through the passage; and a shaft with a sharp portion, wherein theslot and the passage intersect within the anchor body, the shaft beingmovable relative to the anchor body within the slot from a firstposition in which the sharp portion and the passage do not intersect, toa second position in which the sharp portion and the passage intersect.

In Example 2, the subject matter of Example 1 optionally includeswherein the passage defines first and second openings in first andsecond sides of the anchor body through which the suture can extend.

In Example 3, the subject matter of any one or more of Examples 1-2optionally include an eyelet having a first eyelet portion and a secondeyelet portion, wherein a maximum dimension of the first eyelet portionis greater than a maximum dimension of the second eyelet portion.

In Example 4, the subject matter of Example 3 optionally includeswherein a junction is formed between the second eyelet portion and thepassage, the junction being configured to permit movement of the suturefrom the second eyelet portion into the passage across the junction.

In Example 5, the subject matter of Example 4 optionally includeswherein the junction is a portion of the anchor body joining the secondeyelet portion and the passage, which is breakable upon application of apredetermined force against the junction by the suture.

In Example 6, the subject matter of any one or more of Examples 3-5optionally include means for allowing passage of the suture from thesecond eyelet portion into the passage upon application of apredetermined amount of tension on the suture.

In Example 7, the subject matter of any one or more of Examples 1-6optionally include wherein the shaft is lockable relative to the anchorbody within the slot by way of a locking mechanism.

In Example 8, the subject matter of any one or more of Examples 1-7optionally include wherein the shaft has a diameter and an enlargedsection with a diameter that is greater than the diameter of the shaft,the enlarged section forming a step, and wherein a maximumcross-sectional width of the slot is less than the diameter of theenlarged section so that the enlarged section cannot travel into theslot.

In Example 9, the subject matter of Example 8 optionally includeswherein the anchor body comprises a retaining cavity defining a stepconfigured to engage with the step of the enlarged section and preventthe shaft from backing out of the slot.

Example 10 is a system comprising the suture anchor of any of Examples1-9 and a suture, wherein the passage has a width that is anywherebetween about 100-150% of a cross-sectional diameter of the suture.

Example 11 is a suture anchor comprising: an anchor body having a sutureeyelet and a passage extending through the body in a first direction,both the eyelet and the passage being sized to permit a suture totraverse the body therethrough, wherein a junction is formed between theeyelet and the passage that is configured to permit movement of thesuture from the eyelet into the passage across the junction.

In Example 12, the subject matter of Example 11 optionally includeswherein the anchor body further comprises a slot and the suture anchorfurther comprises a shaft with a sharp portion, wherein the slot and thepassage intersect within the anchor body, the shaft being movablerelative to the anchor body within the slot from a first position inwhich the sharp portion and the passage do not intersect, to a secondposition in which the sharp portion and the passage intersect.

In Example 13, the subject matter of any one or more of Examples 11-12optionally include wherein the eyelet comprises a first eyelet portionand a second eyelet portion, wherein a maximum dimension of the firsteyelet portion is greater than a maximum dimension of the second eyeletportion.

In Example 14, the subject matter of Example 13 optionally includeswherein the junction is formed between the second eyelet portion and thepassage.

In Example 15, the subject matter of any one or more of Examples 11-14optionally include wherein the junction comprises a piece of materialinterposed between the eyelet and the passage that is arranged to engagethe suture and allow the suture to pass by the piece of material uponapplication of a predetermined amount of tension to the suture.

Example 16 is a system comprising the suture anchor of any of Examples11-15 and a suture, wherein the passage has a width that is anywherebetween 100-150% of a cross-sectional diameter of the suture.

Example 17 is a method of repairing a tear in human tissue comprising:passing a suture through soft tissue of a patient and through an eyeletof a suture anchor; implanting the suture anchor into an opening formedin a bone of the patient; tensioning a free end of the suture to movethe soft tissue and at least partially reduce the tear; and moving ashaft relative to and within the suture anchor so that the shaftpenetrates through the suture and fixes the suture relative to thesuture anchor.

In Example 18, the subject matter of Example 17 optionally includeswherein the shaft includes a sharp portion and the method comprisespenetrating the suture with the sharp portion.

In Example 19, the subject matter of any one or more of Examples 17-18optionally include locking the shaft relative to the suture anchor.

In Example 20, the subject matter of any one or more of Examples 17-19optionally include applying a predetermined amount of tension to thefree end of the suture so that the suture moves from the eyelet into aseparate passage extending through the suture anchor.

In Example 21, the subject matter of Example 20 optionally includespreventing the suture from moving from the eyelet into the separatepassage if the predetermined amount of tension on the free end of thesuture is not met.

In Example 22, the subject matter of any one or more of Examples 20-21optionally include passing multiple suture strands through the eyelet;tensioning free ends of the suture strands so that the suture strandsmove from the eyelet into the separate passage and become aligned withinthe separate passage; and moving the shaft relative to and within thesuture anchor so that the shaft penetrates through the suture strandsand fixes the suture strands relative to the suture anchor.

BRIEF DESCRIPTION OF THE FIGURES

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing description of examples taken in conjunction with theaccompanying drawings, wherein:

FIG. 1A illustrates a knotless implant in accordance with an example ofthe disclosure, and FIG. 1B illustrates the implant of FIG. 1A attachedto a deployment instrument.

FIG. 1C is a cross-sectional view of the implant of FIG. 1A without thedeployment instrument attached.

FIG. 2 illustrates a suture spike utilized with the knotless implant ofFIGS. 1A and 1C.

FIG. 3A is a perspective view of a handle of the deployment instrumentof FIG. 1B shown in an undeployed state, and FIG. 3B is across-sectional view of the knotless implant of FIG. 1A shown in acorresponding undeployed state.

FIG. 4A is a perspective view of the handle of the deployment instrumentof FIG. 1B shown in a deployed state, and FIG. 4B is a cross-sectionalview of the knotless implant of FIG. 1A shown in a correspondingdeployed state.

FIG. 5 is a side view of the knotless implant of FIG. 4B in the deployedstate.

FIG. 6 is a perspective view of a suture spike in accordance with anexample of the disclosure after being driven through one (1) or moresutures.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate examples of the disclosure, and such exemplifications are notto be construed as limiting the scope of the disclosure any manner.

DETAILED DESCRIPTION

In describing the examples of the presently-disclosed subject matterillustrated and to be described with respect to the drawings, specificterminology will be used for the sake of clarity. However, thedisclosure is not intended to be limited to any specific terms usedherein, and it is to be understood that each specific term includes alltechnical equivalents.

As used herein, the following directional definitions apply. Anteriorand posterior mean nearer the front or nearer the rear of the body,respectively, proximal and distal mean nearer to or further from theroot of a structure, respectively, and medial and lateral mean nearerthe sagittal plane or further from the sagittal plane, respectively. Thesagittal plane is an imaginary vertical plane through the middle of thebody that divides the body into right and left halves. In addition, theterms implant and prosthesis, and variations thereof, can be usedinterchangeably.

Referring to FIG. 1A, a knotless implant or suture anchor 10 is shown.Knotless suture anchor 10 can be used in various surgical procedures,including to repair soft-tissue tears. Merely as examples, knotlessimplant 10 can be used to repair tears of the labrum in the hip orshoulder, tears of the meniscus in the knee, rotator cuff tears, orsoft-tissue tears in the small bones, such as in the hand or foot (e.g.,collateral ligament repair, scapholunate repair, etc.). Stated anotherway, knotless anchor 10 can be used in any context where soft tissue isto be fixed to bone for proper reattachment. As anchor 10 is a knotlessanchor, it does not suffer from many of the deficiencies associated withsoft-tissue repairs that utilize a knot. In addition, anchor 10 caninclude an improved mechanism for securing suture relative to anchor 10.

FIGS. 1A and 1C illustrate knotless implant 10 in a side andcross-sectional view, and show a body 24 of implant 10 as having spikesor barbs 12, optionally flexible, protruding from body 24. Althoughbarbs 12 are shown, any alternative fixation mechanism can be used,including for example knurled or ridged surfaces, threading on body 24,roughened surfaces, ribs, circumferential grooves extending around partor all of the circumference of body 24, or the like. In an example,barbs 12 can be configured to flex when implant 10 is inserted into abore formed in bone. Barbs 12 can therefore act to provide an outwardforce sufficient to penetrate the walls of the bore so as to preventimplant 10 from backing out of the bore.

Implant 10 can also include a distal section 16 without barbs, spikes,or another fixation mechanism. Distal section 16 can be tapered to apoint at a distal-most end of implant 10 for easy insertion into theabove-mentioned bone bore. As shown in FIG. 1A, distal section 16 cantherefore form a substantially conical shape, in an example.

A large eyelet portion 34 sized to receive one (1) or more suturesections 90 (e.g., as shown in FIG. 3B) can be positioned adjacentdistal section 16. It is to be understood that suture sections 90depict, schematically, parts of the same suture or separate suturesaltogether (i.e., depending upon the type of repair being conducted).For instance, in the case of a single-row rotator cuff repair, suturesections 90 can be portions of the same suture, as described in moredetail below in the context of an exemplary surgical method.

In an example, large eyelet portion 34 can be sized to receive one (1),two (2), three (3), four (4), or even more than four (4) suture sections90. Large eyelet portion 34 can transition into a small eyelet portion36 formed through body 24 of implant 10 adjacent its distal section 16.Collectively, large eyelet portion 34 and small eyelet portion 36 candefine an organ-like shape that forms a continuous single eyelet. Statedanother way, large eyelet portion 34 can have a maximum cross-sectionaldimension and small eyelet portion 36 can also have a maximumcross-sectional dimension, where the maximum dimension of small eyeletportion 36 is smaller than that of large eyelet portion 34. Thisdifference in dimensions can act to create a neck region 38 betweeneyelet portions 34, 36 that, as explained in more detail below, causessuture sections 90 to move towards small eyelet portion 36 whentensioned. Neck region 38 can also facilitate alignment of suturesections 90 within small eyelet portion 36. In this regard, small eyeletportion 36 can have a cross-sectional width that is only slightly largerthan the width of suture sections 90 so that, as suture sections 90 aretensioned, such sections 90 become linearly aligned in small eyeletportion 36.

Referring still to FIGS. 1A and 1C, an end of small eyelet portion 36can form a frangible or breakable area 32, which is capable of beingfractured when a certain amount of tension is applied to suture sections90, and thus a certain amount of force is borne on breakable area 32. Inthe depicted example, breakable area 32 can be a solid piece ofconnected material forming an end part of small eyelet portion 36 thatis capable of being broken by suture sections 90. As an example, toallow breakable area 32 the capability of fracturing, it can simply be athin piece of material between small eyelet portion 36 and a verticalslot 26 of implant 10 and/or breakable area 32 can be scored or etchedso that it breaks at a particular location, easily, when a predeterminedamount of force is applied to breakable area 32.

In an alternate example, breakable area 32 can instead already bepre-broken and/or slightly open so that suture sections 90 can passthrough area 32 into vertical slot 26 of implant 10. In such an example,flexible or non-flexible portions of body 24 (e.g., tabs) can come closetogether at the end of small eyelet portion 36 and optionally overlap orbe spaced apart by a small distance (e.g., a distance equal to orslightly smaller than the cross-sectional diameter of suture sections90) so that suture sections 90 can pass by the tabs when a certainamount of tension is applied to sections 90. In the case of non-flexibleportions, such portions of body 24 can be spaced apart by a distancethat is equal to or less than the cross-sectional diameter of suturesections 90 so that sections 90 must be forced through area 32 byexerting a certain amount of tension thereon. In this example, suturesections 32 cannot pass by the non-flexible portions of body 24 unlessthe appropriate tension is applied to suture sections 32 because thedistance separating the non-flexible portions can be less than thecross-sectional diameter of suture sections 90. In another example, area32 can instead be a single flexible tab that flexes to allow sutures 90to pass by the tab. The single flexible tab can entirely close off area32, could be spaced a distance away from a non-flexible part of area 32(e.g., a non-flexible part of the wall defining small eyelet portion36), or could overlap a portion of area 32, such as the wall definingsmall eyelet portion 36.

Because of breakable area 32, a surgeon can be offered tactile feedbackthat suture sections 90 have passed into vertical slot 26, for exampleby feeling resistance at breakable area 32 and then feeling suturesections 90 pass breakable area 32 into vertical slot 26. Thus,breakable area 32 can be any mechanism or means for preventing suturesections 90 from entering vertical slot 26 prematurely (e.g., duringinsertion of implant 10 with suture sections 90 into bone) and thenallowing suture sections 90 to pass into vertical slot 26 and providingtactile confirmation of the same.

Adjacent breakable area 32 can be a vertical slot 26 of implant 10 thatextends a distance along and through body 24. As described in moredetail below, vertical slot 26 can be designed to align one (1) or moresuture sections 90 linearly, as shown for instance in FIG. 4B, so that aspike 50 can be accurately driven through sutures 90. Thus, verticalslot 26 can have a maximum dimension that is roughly the same as thecross-sectional diameter of suture sections 90, optionally a maximumdimension that is only slightly larger than the cross-sectional diameterof suture sections 90. In practice, vertical slot 26 can have a maximumdimension that is anywhere between one-hundred to three hundred percent(100-300%), and more preferably one-hundred to one-hundred and fiftypercent (100-150%) of the cross-sectional diameter of suture sections 90Such dimensions can act to align suture sections 90 in a linear stackedarrangement in vertical slot 26.

Vertical slot 26 can also traverse completely through body 24 of implant10 in a first direction, so as to form a passage with openings 30 on thesides of implant 10. Suture sections 90 can pass within body 24 throughopenings 30, as shown in FIG. 4B. In addition, vertical slot 26 can beclosed in a second direction through body 24 so as to form closedsections 28, as shown in FIG. 1C. In an example, the first direction canbe transverse or alternatively substantially perpendicular to the seconddirection. Vertical slot 26 can also optionally be cylindrical in shape.As shown in the cross-sectional view of FIG. 1C, this can create asituation in which walls of closed sections 28 of vertical slot 26 canbe curved and conform to the curvature of a shaft 51 of spike 50, asdescribed in more detail below. Stated differently, closed sections 28can define walls of vertical slot 26 that have a radius of curvaturethat substantially conforms to or is substantially the same as a radiusof curvature of spike 50. Still referring to FIG. 1C, closed sections 28can also be completely closed along certain sections of vertical slot26, for instance at locations where openings 30 are not present. Atother areas, for example where openings 30 are formed, closed sections28 can define walls that form partially cylindrical surfaces that have aradius of curvature that conforms to or is substantially the same as theradius of curvature of spike 50. Thus, in an example vertical slot 26can form surfaces that conform to the shape of spike 50 to allow spike50 to move longitudinally within vertical slot 26 in a controlled mannerand accurately penetrate suture sections 90. As shown in FIG. 1C,vertical slot 26 can also intersect with the passage formed by openings30.

In an alternate example, vertical slot 26 might not be cylindrical orpartially cylindrical and instead can be any shape that matches orsubstantially conforms to the shape of spike 50 (e.g., oval, triangular,square, polygonal, etc.) In addition, in even further examples, verticalslot 26 can be shaped so as to “key” with spike 50. In other words,vertical slot 26 and spike 50 can take a shape so that spike 50 isrotationally locked or substantially rotationally locked relative to andwithin vertical slot 26. Vertical slot 26 can also have a proximal partor proximal end section that can be tapered to conform to tapering thatmight be present on a portion of spike 50 (e.g., its head 54).

It should be noted that breakable area 32 can extend proximally above adistal-most end of openings 30, as shown in FIG. 1C. As described inmore detail in the context of the surgical method, this positioning canbecome important as spike 50 is driven through suture sections 90.

Suture anchor 10 can further include, near a proximal section 14 ofanchor 10, a projection 21 that can have an external threaded surface 20for interacting with a deployment instrument 70. Projection 21 candefine an internal bore 18 leading to vertical slot 26. Interposedbetween vertical slot 26 and internal bore 18 can be a retaining cavity22. Internal bore 18, in an example, can have a diameter that isslightly smaller than a cross-sectional diameter of a head 54 of spike50 In addition, a proximal-most end of projection 21 can include a taperfor facilitating insertion of head 54 into internal bore 18. Thus, asdescribed in more detail below, the walls of internal bore 18 ofprojection 21 can provide an inward force on head 54—with its largerdiameter—as it travels through internal bore 18. This inward force cancause the partial tube portions 58 to flex inward as head 54 movesthrough internal bore 18.

Alternatively, in another example, projection 21 might not be entirelycylindrical and instead can be a broken cylinder with two (2), three(3), or more than three (3) partially-cylindrical sections that arecapable of flexing outwards. In other words, instead of being completelycylindrical as shown in the depicted example, projection 21 can formpartially-cylindrical arms separated by vertical slots formed in aproximal-distal direction through projection 21. Such “arms” can beindependent of each other and thereby be capable of flexing outwards ashead 54 passes through internal bore 18. In addition, each arm can havean externally-threaded surface 20 that can, collectively, engage withdeployment instrument 70 in the manner set forth below (i.e., via ascrew-and-nut engagement).

A retaining cavity 22 can be positioned distally of internal bore 18,and can be dimensioned to receive head 54 of spike 50, as shown forexample in FIG. 4B. As such, retaining cavity 22 can have a diameter oralternatively a maximum dimension that is greater than that of internalbore 18, such that a step 42 can be formed between retaining cavity 22and internal bore 18. Step 42 can act to retain spike 50 in retainingcavity 22, as described more fully below. In addition, vertical slot 26at its proximal-most end can be dimensioned to be smaller than head 54of spike 50 so that head 54 cannot enter into vertical slot 26 afterbeing received in retaining cavity 22.

An example of spike 50 is shown in FIG. 2. As illustrated, spike 50 canhave a shaft 51 with a sharp tip 52 capable of puncturing suturesections 90. Shaft 51 can have a cross-sectional diameter that isslightly smaller than a cross-sectional diameter of vertical slot 26. Inaddition, in yet another example, shaft 51 can define a radius ofcurvature that conforms to or is the substantially the same as a radiusof curvature of vertical slot 26.

Spike 50 can also include a head 54, which is optionally tapered. Head54 can form a ring-like protrusion 56 that extends partially or entirelyaround a circumference of head 54 for engaging with step 42 of retainingcavity 22. In an example, a single protrusion 56 forming a ring aroundthe circumference of head 54 can be present, although instead a singleor multiple protrusions 56 that extend only partly around thecircumference of head 54 can be included with spike 50. In the case ofthe depicted example of FIG. 2, multiple ring-like protrusions 56 (e.g.,two (2)) can be provided, such that head 54 is bifurcated into two (2)halves. A first protrusion 56 can be present on a first half of head 54,and a second protrusion 56 can be present on a second half of head 54.Each half of head 54 can be formed via an opening 55 extending into andthrough head 55, as shown in FIG. 2. In the depicted example, eachring-like protrusion 56 can be separated from the other to collectivelyform a set of protrusions 56 that are capable of engaging step 42 ofretaining cavity 22. Since, in an example, opening 55 can extend intohead 54 distally of protrusions 56, some flexibility can be provided tohead 54 to allow each half of head 54 to flex inward as head 54 travelsthrough internal bore 18 of projection 21. Thus, each half of head 54 inan example can flex inward as head 54 travels through internal bore 18and then can spring outwards into engagement with retaining cavity 22 toretain spike 50 in retaining cavity 22. In this regard, across-sectional diameter taken at the location of protrusion 56 can begreater than a cross-sectional diameter of internal bore 18, butslightly less than the cross-sectional diameter of retaining cavity 22.

Spike 50 additionally can have a complete or alternatively a partialtube 58 extending from head 54 for interacting with deploymentinstrument 70. As an example, a fully-cylindrical tube 58 can be presenton head 54 or alternatively a series of partially-cylindrical tubeportions 58 can be utilized. In the case of the depicted example, two(2) partially-cylindrical tube portions 58 can extend from head 54. Eachpartially-cylindrical tube portion 58 can extend from a half of head 58,with each tube portion 58 being separated by the extent of opening 55.Collectively, each partially-cylindrical tube portion 58 can thereforeform a set that is capable of engaging with deployment instrument 70, inthe manner described below. Additionally, each partially-cylindricaltube portion 58 can extend towards head 54 and terminate at a step 57that engages with instrument 70 (and with step 42 of retaining cavity 22when inserted therein).

Deployment instrument 70 is shown in FIGS. 1B, 3A-4B, and 5. Referringto FIG. 1B, deployment instrument 70 can have a handle 84, a hollowshaft 86, a button cover 72, and a button mechanism 76. As shown in FIG.3B, shaft 86 of instrument 70 can be hollow and can have a distal-mostend with an internally-threaded surface 88 for engaging withexternally-threaded surface 20 of projection 21 of implant 10. Whenengaged therewith, the distal-most end of shaft 86 can abut a step 23 ofimplant 10. Hollow shaft 86 can have a cross-sectional diameter that isapproximately the same as or only slightly greater than thecross-sectional diameter of head 54 of spike 50, at protrusions 56.

A pusher tube 80 can also be disposed in hollow shaft 86 of instrument70. Pusher tube 80 can be a hollow tube 80 with an internal diameterthat can be approximately the same as or slightly greater than anexternal diameter of partially-cylindrical tube portions 58. Thus, tube80 can be placed over tube portions 58 and moved distally until pushertube 80 reaches and engages step 57 of spike 50. At the same time,pusher tube 80 can have an external diameter that is less than aninternal diameter of hollow shaft 86 so that pusher tube 80 can movelongitudinally relative to and within shaft 86. In this regard, pushertube 80 can be connected to button mechanism 76, as shown in FIGS. 3A-B.Actuation of button mechanism 76 can cause pusher tube 80 to movedistally relative to and within hollow shaft 86, while releasing buttonmechanism 76 optionally can allow pusher tube 80 to move proximally. Abutton cover 72 and a latch 74 therefor can also be provided withinstrument 70 to ensure that button mechanism 76 is covered duringinitial implantation of implant 10, and button mechanism 76 is notprematurely actuated.

In an example, although not shown, button mechanism 76 can be anymechanism capable of moving pusher tube 80 distally and/or proximally,as recognized by a person of skill in the art. As an example, buttonmechanism 76 can be a button connected by one (1) or more linkages topusher tube 80, such that depressing button mechanism 76 causes pushertube 80 to move distally. In addition, the linkages can be associatedwith a spring or other biasing mechanism, such that releasing buttonmechanism 76 causes the spring to actuate and force pusher tube 80proximally. In an example, a catch or other mechanism, with a release,can be provided with instrument 70 so that button mechanism 76 can bedepressed, engage with the catch, and subsequently be released via arelease mechanism to return button mechanism 76 back to its initialcondition. Other mechanisms for moving pusher tube 80 proximally anddistally are, of course, contemplated.

In an example, deployment instrument 70 can also include a viewingaperture or slot 78 for confirming that button mechanism 76 has beenfully deployed, thereby validating that pusher tube 80 has been fullyadvanced distally inside hollow shaft 86.

Methods of implanting implant 10 and performing a soft-tissue repairusing implant 10 will now be disclosed. The methods set forth below aremerely exemplary, and although certain steps may be set forth in aparticular order, the order is not required and steps may be performedin a different order than set forth. The particular method below, usedmerely as an example, is a rotator cuff repair. It is contemplated,however, that suture anchor 10 can be used in any repair where softtissue is to be drawn back to its natural condition in the body.

In an example, the method comprises first establishing an access portalthrough the skin and tissue of a shoulder of the patient (e.g., using apercutaneous cannula). Again, other anatomical locations arecontemplated, such as repairs in the knee, hips, ankles, or other smallbones. With the access portal established, one (1) or more sutures canbe passed through the access portal to the surgical site and through thesoft tissue, in this case the rotator cuff in the patient's shoulder.The one (1) or more sutures can be inserted through the soft tissue atone (1) or more locations. As an example, a suture can be placed throughthe soft tissue at two (2) locations to establish an inverted mattressstitch for a single-row repair. Many other suture configurations arepossible, including where multiple sutures are used, such as the sutureconfigurations used for double-row repairs or trans-osseous equivalent.A single-row repair is discussed below merely as an exemplary use ofsuture anchor 10, it being understood that other repairs are possible.

As shown in FIG. 3B, after placement of a suture through the soft tissueusing an inverted mattress stich, two (2) suture sections 90 can extendfrom the soft tissue and form tissue-facing 92 and free end sides 94 ofsuture sections 90. Free ends 94 can be withdrawn from the access portaland threaded through large eyelet portion 34 of suture anchor 10 usingsuitable instrumentation, such as a loop of material used as suturethreader. With free ends 94 of suture sections 90 through large eyeletportion 34, the surgeon can then grasp free ends 94 and insert sutureanchor 10 through the access portal using deployment instrument 70.Suture anchor 10 can be pre-attached to deployment instrument 70 or thesurgeon can attach suture anchor 10 to deployment instrument 70 afterfree ends 94 of suture sections 90 are drawn through large eyeletportion 34. In particular, internal threading 88 of shaft 86 ofinstrument can be threaded onto external threading 20 on projection 21of suture anchor 10.

The surgeon can then grasp free ends 94 of suture sections 90 and usehandle 84 of instrument 70 to insert suture anchor 10 through the accessportal into the patient's shoulder. Free ends 94 of suture sections 90can be tensioned by the surgeon to remove slack as suture anchor 10 ismoved distally through the access portal towards the patient's tornrotator cuff. Previously, or at any point before suture anchor 10 isdriven into bone, a suitable awl, pilot drill, or other instrument canbe used by the surgeon to create an opening in bone of the patient forreceiving suture anchor 10. In this case, the opening can be formed inthe patient's humerus. Suture anchor 10 can then be positioned at thesite of the bone opening and driven into the opening, distal pointed end16 first, until anchor 10 is fully seated in the bone. In this regard,the surgeon can elect to use a mallet or other instrument to tap on aproximal end of deployment instrument 70 and cause suture anchor 10 tobecome embedded in the bone hole. Deployment instrument 70 can thereforealso act as an insertion instrument for suture anchor 10. As sutureanchor 10 is being inserted, barbs or spikes 12 can engage the walls ofthe bone hole, and optionally flex and provide an outward forcesufficient to embed themselves in the bone and provide ample pull-outresistance for suture anchor 10.

With suture anchor 10 embedded in the bone hole, or optionally priorthereto, the surgeon can exert tension on free ends 94 of suturesections 90 and cause the portions of suture sections 90 extendingthrough large eyelet portion 34 (e.g., the two (2) suture sections 90 ofthe single suture in the single-row repair context) to move towardssmall eyelet portion 36. Neck 38 between eyelets 34, 36 can be useful inthis instance to draw suture sections 90 extending through large eyeletportion 34 towards and into small eyelet portion 36. Because smalleyelet portion 36 can have a cross-sectional width that is only slightlylarger than the width of suture sections 90, the parts of suturesections 90 extending through suture anchor 10 can become aligned insmall eyelet portion 36. In other words, such suture sections 90 canbecome stacked linearly next to each other within small eyelet portion36, similar to as shown in FIG. 4B where the aforementioned suturesections 90 are linearly aligned within vertical slot 26.

It should be noted that suture anchor 10 can be designed to allowtension to be applied to free ends 94 of suture sections 90 when anchor10 is embedded in bone. Thus, there can be room between the walls of thebone hole and body 24 of suture anchor to allow tensioning of free ends94 and movement of the suture or sutures relative to body 24.

As additional tension is applied to free ends 94 by the surgeon, andbecause tissue-engaging side 92 of suture sections 90 can be engagedwith soft tissue, suture sections 90 extending through implant 10 canforce themselves against breakable area 32 and cause breakable area 32to fracture. Alternatively, as contemplated in the different examplesabove, breakable area 32 can instead be pre-broken, open, or utilize anyother features set forth herein to allow the aforementioned parts ofsuture sections 90 to pass by breakable area 32 upon the application ofa sufficient amount of force/tension. At such point, the aligned partsof suture sections 90 can travel into vertical slot 26 of suture anchor10, where such suture sections 90 can remain aligned. Indeed, sincevertical slot 26 can have a maximum dimension that is anywhere betweenone-hundred to one-hundred and ninety five percent (100-195%), morepreferably one-hundred to one-hundred and fifty percent (100-150%) ofthe cross-sectional diameter of the suture, each suture section 90 canremain substantially linearly aligned within vertical slot 26.

At this stage, the surgeon can elect to apply further tension to freeends 94 to draw the soft tissue, in this instance the patient's rotatorcuff, back into its normal anatomical position. As an example, thepatient's rotator cuff can be drawn back into position against thehumerus so that the rotator cuff properly reattaches to the humerusduring healing (e.g., in the case of a tear where the rotator cuff hasdetached).

After sufficient tension is applied and the soft tissue tear is reduced,the surgeon can use deployment instrument 70 to deploy spike 50 throughsuture sections 90 extending through vertical slot 26 to fix suchsections 90 relative to implant body 24 and complete the repair. In anexample, the surgeon can open button cap 72 and depress button mechanism76 to cause pusher tube 80 to move distally within hollow shaft 86.Because pusher tube 80 can contact step 57 of spike 50 inside hollowshaft 86, such distal movement of pusher tube 80 can cause spike 50 toadvance distally within hollow shaft 86 until it enters implant 10, inparticular inner bore 18 of projection 21. A press-fit can beestablished between pusher tube 80 and tube portions 58 on spike 50 sothat spike 50 can be moved easily proximally and/or distally withinhollow shaft 86.

With further distal advancement of pusher tube 80, head 54 and inparticular protrusions 56 thereof can advance into inner bore 18. Head54 of spike 50 and/or projection 21 of implant 10 can flex at this pointto accommodate the dimensional differences between protrusions 56 ofspike 50 and inner bore 18 of projection 21 (e.g., the cross-sectionaldiameter of head 54 at protrusions 56 being greater than thecross-sectional diameter of inner bore 18). At the same time, sharp tip52 of spike 50 can penetrate suture sections 90 extending throughvertical slot 26. A schematic example of a spike 50 penetrating abraided suture is shown in FIG. 6. As shown, spike 50 can, more or less,become inserted through and/or between the braid strands of suturesections 90 and not damage the integrity of suture sections 90 to anyappreciable degree. Alternatively, it is of course contemplated thatnon-braided sutures (e.g., monofilaments) or any other type of suturecould be used and spike 50 could penetrate the same without damage tothe suture's structural integrity.

Referring to FIGS. 4A-B, with button mechanism 76 fully depressed, head54 of spike 50 can become seated in retaining cavity 22 of suture anchor10 and be prevented from moving further distally due to a dimensionalinterference between head 54 and vertical slot 26. In particular, ashead 54 moves distally in inner bore 18, ultimately protrusions 56 canpass step 42 of retaining cavity 22 and protrusions 56 can snap intoposition within retaining cavity 22. In other words, head 54 of spike 50can have sufficient room to become unflexed in retaining cavity 22,allowing protrusions 56 to expand outwards in retaining cavity 22. Atthis point, spike 50 cannot back out of body 24 of implant 10 due tointerference between step 57 of spike and step 42 of retaining cavity22, and spike 50 cannot move significantly in a distal direction due thefact that vertical slot 26 is smaller in width than head 54. If spike 50were moved proximally, steps 42, 57 would engage and prevent spike 50from withdrawing out of implant 10. At this stage, suture sections 90can become fixed relative to suture anchor 10, in a knotless manner, dueto spike 50 penetrating suture sections 90 extending through verticalslot 26. The linear alignment of suture sections 90 in vertical slot 26can facilitate penetration by spike 50. Thus, the patient's soft tissueis repaired in a reliable and knotless manner.

It should be noted that spike 50 can provide for a situation in which itis virtually impossible for suture sections 90 to slide relative tosuture anchor 10 once spike 50 is driven through suture sections 90.This is in contrast to certain suture anchors, which utilize an internalscrew to bear upon a suture extending through the suture anchor to fixthe suture relative to the anchor. In these situations, the suture isonly fixed via friction between the internal screw of the anchor and theanchor itself. The suture could therefore suffer from slippage if thefriction fit is insufficient, if enough force is borne on the sutureafter implantation, and/or if the internal screw loosens. With thepresent suture anchor 10, suture sections 90 cannot slip relative tosuture anchor 10 as suture sections 90 can be penetrated with spike 50and are not fixed merely by friction.

Lastly, the surgeon can unscrew deployment instrument 70 from thedeployed suture anchor 10 and withdraw deployment instrument 70 out ofthe access portal in the patient's shoulder. Additionally, the surgeoncan trim any excess suture material resulting from free ends 94 ofsuture sections 90 extending outside of the bone hole. The repair canthen be completed.

In the devices shown in the figures, particular structures are shown asbeing adapted for use as a suture anchor or in a method of implantationthereof. The disclosure also contemplates the use of any alternativestructures for such purposes, including structures having differentlengths, shapes, and/or configurations. For example, although suturespike 50 is shown as being non-threaded, other examples using differentdeployment and/or locking techniques can use a threaded suture spike 50.As an example, in an alternate example suture anchor 10 can omit thestructure of inner bore 18 and/or retaining cavity 22 in favor of usinga threaded locking and/or advancement mechanism. As yet another example,a bayonetted locking mechanism can be used instead of retaining cavity22. In the threaded example, part of shaft 51 of spike 50 can bethreaded and, likewise, portions or all of vertical slot 26 can bethreaded. To advance threaded spike 50, the surgeon can simply insertthreaded spike 50 into engagement with threaded vertical slot 26 androtate spike 50 so that spike 50 distally advances within vertical slot26 to puncture suture sections 90. The threaded engagement between spike50 and vertical slot 26 can also prevent spike 50 from withdrawing outof vertical slot 26, and thus implant 10.

Alternatively, threading can be applied only to a portion of spike 50(e.g., its head 54) and, likewise, threading can be applied only to aportion of vertical slot 26 (e.g., a proximal part thereof). Spike 50can then be driven through suture sections 90 by a pushing motion,without rotation, and then locked relative to implant via threading head54 of spike 50 into the threaded part of vertical slot 26. Other lockingand/or advancement mechanisms for spike 50 are also contemplated, ofcourse. In addition, as noted in more detail above, spike 50 canalternatively be non-threaded and keyed to the shape of vertical slot 26so that spike 50 cannot rotate relative to implant 10 as it is beingdriven through suture sections 90.

In a further example, spike 50 can be omitted altogether and a differentlocking mechanism for suture sections 90 can be used. As an example,certain structures can be utilized within vertical slot 26 to locksuture sections 90 relative to suture anchor 10 in a lateral direction.In an example, such structures could be a set of tapered surfaces thatcome closer together proximally in vertical slot 26, such that, assuture sections 90 move proximally in vertical slot 26, sections 90engage the tapered surfaces of vertical slot 26 and become fixed viafriction and/or compression relative to suture anchor 10. In thisexample, the aforementioned tapered surfaces can also usefriction-increasing techniques to improve the locking of suture sections90. As an example, the tapered surfaces can be roughened, ribbed, orinclude ridges that dig into suture sections 90 as they are pulledproximally in vertical slot 26. Thus, vertical slot 26 can employ otherlocking mechanisms for suture sections 90.

It will be readily understood to those skilled in the art that variousother changes in the details, material, and arrangements of the partsand method stages which have been described and illustrated in order toexplain the nature of the inventive subject matter can be made withoutdeparting from the principles and scope of the inventive subject matteras expressed in the subjoined claims.

It will also be appreciated that the various dependent claims, examples,and the features set forth therein can be combined in different waysthan presented above and/or in the initial claims. For instance, anyfeature(s) from the above examples can be shared with others of thedescribed examples, and/or a feature(s) from a particular dependentclaim may be shared with another dependent or independent claim, incombinations that would be understood by a person of skill in the art.

1-6. (canceled)
 7. A method of repairing a tear in human tissue comprising: passing a suture through soft tissue of a patient and through an eyelet of a suture anchor; implanting the suture anchor into an opening formed in a bone of the patient; tensioning a free end of the suture to move the soft tissue and at least partially reduce the tear; and moving a shaft relative to and within the suture anchor so that the shaft penetrates through the suture and fixes the suture relative to the suture anchor.
 8. The method of claim 7, wherein the shaft includes a sharp portion and the method comprises penetrating the suture with the sharp portion.
 9. The method of claim 7, further comprising locking the shaft relative to the suture anchor.
 10. The method of claim 7, further comprising applying a predetermined amount of tension to the free end of the suture so that the suture moves from the eyelet into a separate passage extending through the suture anchor.
 11. The method of claim 10, further comprising preventing the suture from moving from the eyelet into the separate passage if the predetermined amount of tension on the free end of the suture is not met.
 12. The method of claim 10, further comprising: passing multiple suture strands through the eyelet; tensioning free ends of the suture strands so that the suture strands move from the eyelet into the separate passage and become aligned within the separate passage; and moving the shaft relative to and within the suture anchor so that the shaft penetrates through the suture strands and fixes the suture strands relative to the suture anchor.
 13. The method of claim 7, wherein moving the shaft relative to and within the suture anchor so that the shaft penetrates through the suture includes inserting the shaft between a plurality of braid strands of the suture.
 14. A method of repairing a tear in human tissue comprising: passing a suture through soft tissue of a patient and through an eyelet of a suture anchor; implanting the suture anchor into an opening formed in a bone of the patient; tensioning a free end of the suture to move the soft tissue and at least partially reduce the tear; moving a shaft relative to and within the suture anchor until the shaft penetrates through the suture; and further moving the shaft distally relative to the suture anchor until a protrusion on the shaft becomes retained in a retaining cavity of the suture anchor.
 15. The method of claim 14, wherein the protrusion is located at a proximal end portion of the shaft.
 16. The method of claim 14, wherein the shaft includes a sharp portion and the method comprises penetrating the suture with the sharp portion.
 17. The method of claim 14, further comprising locking the shaft relative to the suture anchor.
 18. The method of claim 14, further comprising applying a predetermined amount of tension to the free end of the suture so that the suture moves from the eyelet into a separate passage extending through the suture anchor.
 19. The method of claim 18, further comprising preventing the suture from moving from the eyelet into the separate passage if the predetermined amount of tension on the free end of the suture is not met.
 20. The method of claim 18, further comprising: passing multiple suture strands through the eyelet; tensioning free ends of the suture strands so that the suture strands move from the eyelet into the separate passage and become aligned within the separate passage; and moving the shaft relative to and within the suture anchor so that the shaft penetrates through the suture strands and fixes the suture strands relative to the suture anchor.
 21. A method of repairing a tear in human tissue comprising: passing one or more sutures having multiple suture strand sections through soft tissue of a patient and through an eyelet of a suture anchor; implanting the suture anchor into an opening formed in a bone of the patient; tensioning the one or more sutures; aligning the multiple suture strand sections in the suture anchor; and moving a shaft relative to and within the suture anchor until the shaft penetrates through the multiple suture strand sections to fix the multiple suture strand sections relative to the suture anchor.
 22. The method of claim 21, further comprising: moving the shaft further distally relative to the suture anchor until a protrusion on a proximal end of the shaft becomes retained in a retaining cavity of the suture anchor.
 23. The method of claim 21, wherein the shaft includes a sharp portion and the method comprises penetrating the multiple suture strand sections with the sharp portion.
 24. The method of claim 21, further comprising locking the shaft relative to the suture anchor.
 25. The method of claim 21, further comprising applying a predetermined amount of tension to a free end of the one or more sutures so that the multiple suture strand sections move from the eyelet into a separate passage extending in a longitudinal direction through the suture anchor.
 26. The method of claim 25, further comprising preventing the multiple suture strand sections from moving from the eyelet into the separate passage if the predetermined amount of tension on the free end of the one or more sutures is not met. 